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intermedics polyflex-model 483-04 lead
Intermedics
Summary: The Intermedics Polyflex-Model 483-04 Lead is a medical device used in cardiac pacing systems. It is primarily used by cardiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K812991 ↗
Decision Date
November 16, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Polyflex-Model 483-04 Lead was cleared through the FDA 510(k) pathway on November 16, 1981. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Intermedics Polyflex-Model 483-04 Lead is a cardiac pacing lead designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It is an essential component of a pacing system, typically implanted in patients with bradycardia or other rhythm disorders. The lead is designed to be flexible and durable, accommodating the movements of the heart and body.
Clinical Applications
This lead is commonly used in procedures involving the implantation of pacemakers, especially in patients with conditions such as atrioventricular block or sick sinus syndrome. Cardiologists and electrophysiologists in hospital settings typically perform these procedures. The device is suitable for adult and elderly patients who require long-term cardiac rhythm management.
Indications for Use
The FDA indications for the Intermedics Polyflex-Model 483-04 Lead include use in patients who need cardiac pacing due to conditions like slow heart rate or irregular heart rhythms. It is intended for those who require a reliable connection between a pacemaker and the heart.
Practical Considerations
The lead comes in various lengths to accommodate different patient anatomies and is compatible with most pacemaker systems. Implantation requires precise technique to ensure proper placement and function, typically involving fluoroscopic guidance.
Frequently Asked Questions
What is the Intermedics Polyflex-Model 483-04 Lead used for?
It is used in cardiac pacing systems to maintain proper heart rhythm in patients with rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to conditions like bradycardia or irregular heart rhythms.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.